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Live Webinar: Best Practices in Preparation for an FDA Computer System Audit

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

Description

March 15, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

"The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state."

Why Should You Attend

"Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

Applying best practices will ultimately result in minimizing the time and cost of regulatory audits, and the impact on operations and productivity. While there are many sources of information to help you develop a good validation program, this course will narrow down the most overall cost-effective approach that is tried and true.

It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.

Areas Covered

There are specific best practices to be followed that will ensure you are fully prepared to defend your program and prove that you have thoroughly validated your computer systems that are subject to regulatory scrutiny. Being prepared will ensure a much easier interaction with the regulatory agency and will minimize the time and cost of the audit. A company’s readiness may also minimize the risk of findings and citations by showing the auditors that you have done due diligence and are able to respond adequately to all questions and requests for information in a timely manner.

This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.